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Roche at-home Covid tests receive US FDA nod

On Friday, Basel-based Roche announced that the US Food and Drug Administration has granted Emergency Use Authorisation for its at-home rapid test. The tests will be made available over-the-counter at pharmacies and retailers throughout the United States starting in January 2022.

“The Covid-19 pandemic continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities,” said Thomas Schinecker, CEO, Roche Diagnostics, in a press statementExternal link.

The Covid-19 At-Home Test uses a nasal swab sample to enable individuals to self-test at home and receive results in about 20 minutes for coronavirus and all known variants of concern, including Omicron.

The at-home tests or “self tests” have been widely used in Switzerland since this spring. For a period of time, a certain number of them were available to the population at no-cost. Studies of the accuracy of the results vary with some showing that the test detects positive cases when there is a high viral loadExternal link. One study from the University of Bern showed that the tests picked up 44% of symptom-free cases that were positive through a PCR test.

The company has a distribution agreement with SD Biosensor who has also been involved in the launch of a range of Covid tests. A key consideration for the authorisation, writes Roche, was its ability to deliver large quantities of tests and ramp up manufacturing to meet future demands. In a statement, the company said “it has the capacity to produce tens of millions of tests per month to help support the pandemic response”.

[Source: SWI, Bern, 26Dec21]

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small logoThis document has been published on 28Dec21 by the Equipo Nizkor and Derechos Human Rights. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.